Mri compatible medical device temperature monitoring system and method

ABSTRACT

A temperature monitoring system for a medical device comprises an optical transmit/receive unit, an elongate optical fiber having a proximal end, a distal end, and an inner core extending between the proximal end and the distal end, and one or more fiber Bragg grating elements formed in the inner core of the optical fiber. The optical fiber is operably coupled to the transmit/receive unit at the proximal end. At least a portion of the optical fiber is also operably coupled to a medical device and is structured to measure temperature at one or more temperature sensing locations on the medical device.

FIELD OF THE INVENTION

The invention relates to medical devices used in diagnostic andtherapeutic procedures and in particular to a system and method formonitoring temperature of a medical device in a magnetic resonanceimaging environment.

BACKGROUND OF THE INVENTION

MRI has achieved prominence as a diagnostic imaging modality, andincreasingly as an interventional imaging modality. The primary benefitsof MRI over other imaging modalities, such as X-ray, include superiorsoft tissue imaging and avoiding patient exposure to ionizing radiationproduced by X-rays. MRI's superior soft tissue imaging capabilities haveoffered great clinical benefit with respect to diagnostic imaging.Similarly, interventional procedures, which have traditionally usedX-ray imaging for guidance, stand to benefit greatly from MRI's softtissue imaging capabilities. In addition, the significant patientexposure to ionizing radiation associated with traditional X-ray guidedinterventional procedures is eliminated with MRI guidance.

MRI uses three fields to image patient anatomy: a large static magneticfield, a time-varying magnetic gradient field, and a radiofrequency (RF)electromagnetic field. The static magnetic field and time-varyingmagnetic gradient field work in concert to establish both protonalignment with the static magnetic field and also spatially dependentproton spin frequencies (resonant frequencies) within the patient. TheRF field, applied at the resonance frequencies, disturbs the initialalignment, such that when the protons relax back to their initialalignment, the RF emitted from the relaxation event may be detected andprocessed to create an image.

Each of the three fields associated with MRI present safety risks topatients when a medical device is in close proximity to or in contacteither externally or internally with patient tissue. One importantsafety risk is the heating that can result from an interaction betweenthe RF field of the MRI scanner and the medical device (RF-inducedheating), especially medical devices which have elongated conductivestructures with tissue contacting electrodes, such as electrode wires inpacemaker and implantable cardioverter defibrillator (ICD) leads,guidewires, and catheters. Thus, as more patients are fitted withimplantable medical devices, and as use of MRI diagnostic imagingcontinues to be prevalent and grow, the need for safe devices in the MRIenvironment increases.

A variety of MRI techniques are being developed as an alternative toX-ray imaging for guiding interventional procedures. For example, as amedical device is advanced through the patient's body during aninterventional procedure, its progress may be tracked so that the devicecan be delivered properly to a target site. Once delivered to the targetsite, the device and patient tissue can be monitored to improve therapydelivery. Thus, tracking the position of medical devices is useful ininterventional procedures. Exemplary interventional procedures include,for example, cardiac electrophysiology procedures including diagnosticprocedures for diagnosing arrhythmias and ablation procedures such asatrial fibrillation ablation, ventricular tachycardia ablation, atrialflutter ablation, Wolfe Parkinson White Syndrome ablation, AV nodeablation, SVT ablations and the like. Tracking the position of medicaldevices using MRI is also useful in oncological procedures such asbreast, liver and prostate tumor ablations; and urological proceduressuch as uterine fibroid and enlarged prostate ablations.

In many of the foregoing cases, elongated or large surface area metallicstructures may be present in interventional devices that are used duringa procedure to deliver therapy or provide a diagnosis, implanted devicesthat are placed within the body to provide therapy or deliver adiagnosis, or the tools used to deploy or deliver the interventional orimplanted device to the patient. Examples of interventional deviceshaving metallic structures may include plaque excision devices, embolictraps, electrophysiology catheters, biopsy needles/tools, and stem celldelivery catheters. Examples of implanted devices having metallicstructures may include cochlear implants, pacemakers, implantablecardioverter defibrillators, Insulin pumps, nerve stimulators, leadwires, prosthetic heart valves, hemostatic clips, and non-ferromagneticstapedial implants. Finally, examples of deployment or delivery toolshaving metallic structures may include catheters, sheaths, introducers,guidewires, transseptal devices, and trochars.

As appreciated by those skilled in the art, these metallic structuresmay undergo heating during an MRI scanning process. This heating may becaused by numerous factors, including but not limited to eddy currentsfrom MRI gradient switching, RF induced heating due to electromagneticinteractions between the metallic structure and the MRI transmit coil,and large current densities at metal/tissue interfaces (where heatingmay occur in both the metallic structure as well as the connectedtissue). In all of these cases, it may be important to monitor thedevice temperature at a single or multiple points such that a safe levelof device heating may be maintained.

In some of the foregoing cases, the interventional procedure may alsoinclude delivery of ablative therapy in the form of either heat, such asby radiofrequency delivery, laser delivery, microwave delivery, orhighly focused ultrasound delivery, or freezing, such as by delivery ofa cryogenic fluid. When the interventional procedure includes thedelivery of ablative energy, it may be especially important to monitorthe temperature of the therapy delivery point such that the therapy canbe appropriately titrated. Thus, temperature monitoring is an importantstep for interventional procedures performed under MRI guidance.

Numerous methods and devices for measuring temperature are known andused in the medical device field. One exemplary device for measuringtemperature is a thermocouple. Generally speaking, a thermocouple may beany conductor that generates a voltage when subjected to a thermalgradient. Thermocouples typically use two dissimilar metals to create acircuit in which the two legs generate different voltages that may bemeasured to determine a temperature value. Thermopile devices operate ina similar manner and are constructed by connecting a plurality ofthermocouples in series or parallel. Another exemplary device formeasuring temperature is a resistance thermometer or resistancetemperature detector (RTD). This type of device operates by exploitingthe predictable change in electrical resistance of materials withchanging temperature, and is typically made of platinum. Yet anotherexemplary device for measuring temperature is a thermistor. Thermistorsutilize a type of resistor that exhibits a varying resistance accordingto its temperature. Both positive and negative coefficient devices exist(PTC and NTC). As opposed to RTDs which are formed from pure metals,thermistors are generally formed from a ceramic or polymer.

One exemplary method of measuring temperature is known as radiationthermometry. Every object emits radiant energy, and the intensity ofthis radiation per unit area is a function of its temperature. Inradiation thermometry, infrared thermometers are used to measureintensity of radiation. Radiation thermometry is also commonly referredto as optical pyrometry, radiometric temperature measurement, infraredthermometry, optical fiber thermometry, two color radiation thermometry,and infrared thermometry. Another exemplary method of measuringtemperature is based upon the semiconductor absorption theory, and maybe referred to as the method of “spectral analysis.” Spectral analysisuses gallium arsenide (GaAs) tipped fibers, and operates on theabsorption/transmission properties of gallium arsenide crystalsemiconductors. As the crystal temperature increases, its transmissionspectrum shifts to a higher wavelength. The relationship betweentemperature and the wavelength at which the absorption shift takes placeis predictable. The temperature value may be obtained by analyzing theabsorption spectrum. Yet another method of measuring temperature isknown as fluoroptic thermometry. When thermo-sensitive phosphor isstimulated with red light it emits light over a broad spectrum in thenear infrared region. The time required for the fluorescence to decay isdependent upon the sensor's temperature. The measured decay time may beconverted to temperature using a calibrated conversion table.

The foregoing known devices and methods for measuring temperature havenumerous disadvantages and limitations. Thermocouples are inaccurate,susceptible to MRI-induced heating due to their metallic nature, andrequire conductive leads that can create a non-MRI safe condition.Resistance thermometers or RTDs require conductive leads that can createa non-MRI safe condition and are mechanically fragile. Thermistors alsorequire conductive leads that can create a non-MRI safe condition andare mechanically fragile. With regard to radiation thermometry,radiation amplitude at body temperatures is small and requires largearea detectors. Further, it is difficult to provide sufficient lensingat the tip of the catheter. Spectral analysis is expensive, potentiallytoxic in the body due to the use of gallium arsenide, and the fibers aredifficult to manufacture. Fluoroptic thermometry is also an expensiveand inaccurate process that requires calibration before each use.Further, it is difficult to localize the temperature measurement point,and process testing cannot be exposed to ambient light.

Current technologies for measuring temperature in an MRI environment areinadequate. Therefore, what is needed is a real-time temperaturemeasurement system that is MRI safe, accurate, biocompatible, and costeffective.

BRIEF SUMMARY OF THE INVENTION

The present invention solves the foregoing needs by providing a novelMRI compatible temperature measurement system and method for a medicaldevice. In one exemplary embodiment, a temperature monitoring system isprovided that includes an optical transmit/receive unit, an elongateoptical fiber having a proximal end, a distal end, and an inner coreextending between the proximal end and the distal end, and one or morefiber Bragg grating elements formed in the inner core of the opticalfiber. The optical fiber is operably coupled to the transmit/receiveunit at the proximal end. At least a portion of the optical fiber isalso operably coupled to a medical device and is structured to measuretemperature at one or more temperature sensing locations on the medicaldevice.

In accordance with another aspect of the present invention, a method ofestimating temperature is provided that generally includes the steps ofselecting a plurality of known calibration temperature values,determining a bulk wavelength for each of the calibration temperaturevalues, formulating a calibration data set that includes the pluralityof known temperature values and the corresponding plurality of bulkwavelengths, and using the calibration data set to determine anestimated current temperature value based upon a current bulkwavelength, wherein the current temperature value is estimated basedupon one or more data points in the calibration data set.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagram illustrating one exemplary temperature monitoringsystem in accordance with the present invention.

FIG. 2 is a diagram illustrating a modified design for the temperaturemonitoring system of FIG. 1.

FIG. 3 is a block diagram illustrating the components of an exemplaryoptical transmit/receive circuitry unit.

FIG. 4 is a block diagram illustrating the basic operation of thetemperature monitoring system of FIG. 1.

FIG. 5 is a block diagram illustrating the basic operation of analternative temperature monitoring system in accordance with the presentinvention.

FIG. 6 is an exemplary embodiment of an implantable device having thetemperature monitoring system of FIG. 1 embedded therein.

FIG. 7 is an exemplary embodiment of an ablation catheter having thetemperature monitoring system of FIG. 5 embedded therein.

FIG. 8 is an exemplary embodiment of a biopsy needle device having thetemperature monitoring system of FIG. 1 embedded therein.

FIG. 9 is an exemplary embodiment of a stem cell delivery device havingthe temperature monitoring system of FIG. 1 embedded therein.

FIG. 10 is an exemplary embodiment of an interventional device deliverysystem having the temperature monitoring system of FIG. 1 embeddedtherein.

FIG. 11 is an exemplary embodiment of another alternative temperaturemonitoring system in accordance with the present invention.

FIG. 12 is a flow diagram illustrating exemplary steps in a process fordetermining bulk wavelength in accordance with one embodiment of thepresent invention.

FIG. 13 is a graphical illustration showing an exemplary data setconsisting of transmit wavelengths and associated received lightmagnitudes.

FIG. 14 is a graphical illustration depicting an exemplary bulk range onthe data set of FIG. 13.

FIG. 15 is a flow diagram illustrating exemplary steps in a temperaturecalibration process in accordance with one embodiment of the presentinvention.

FIG. 16 is a graphical illustration depicting a calibration data setcollected during a temperature calibration process.

FIG. 17 is an exemplary calibration data set in table form.

FIG. 18 is a flow diagram illustrating exemplary steps in a temperaturemeasuring process in accordance with one embodiment of the presentinvention.

FIG. 19 is a graphical illustration depicting a step for determining anestimated temperature value using interpolation.

FIG. 20 is a graphical illustration depicting a step for determining anestimated temperature value using extrapolation.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is a diagram illustrating one exemplary temperature monitoringsystem 10 in accordance with the present invention. As illustrated inFIG. 1, the temperature monitoring system 10 generally includes anoptical transmit/receive circuitry unit 12 and a fiber 14 operablycoupled on a proximal end 16 to the optical transmit/receive circuitry12. The fiber 14 may preferably be formed from glass or plastic, andfurther includes a fiber Bragg grating (FBG) element 18 adjacent adistal end 20. In the exemplary embodiment of FIG. 1, the temperaturemonitoring system 10 is shown as being used with a catheter 22. Thecatheter 22 includes a main body 24 structured to receive at least aportion of the fiber 14 and a catheter handle 26 structured to begrasped and held by a surgeon or support device. As will be appreciatedby those skilled in the art, the catheter 22 is represented genericallyherein and may be structured for use in numerous types of medicalprocedures to deliver therapy or provide a diagnosis.

The fiber 14 of the temperature monitoring system 10 may be structuredsuch that it is completely removable from the catheter 22 and may bereused in a different catheter or another type of medical device.Alternatively, as illustrated in FIG. 2, the fiber may comprise a firstportion 14′ that is fixedly coupled to the optical transmit/receivecircuitry 12 and a second portion 14″ that is fixedly coupled to thecatheter 22. As will be appreciated by those skilled in the art, thefirst and second portions 14′ and 14″ may be formed as separate fibersegments. In this alternative fiber design, the catheter handle 26 mayinclude a connector 28 that allows the first portion 14′ of the fiber tobe optically coupled to the second portion 14″ to transmit light wavestoward the FBG element 18. Optionally, the optical transmit/receivecircuitry 12 may include a connector 29 that allows the first portion14′ to be removably coupled thereto. As will be appreciated by thoseskilled in the art, connectors 28 and 29 may comprise any suitableconnection means without departing from the intended scope of thepresent invention.

The FBG element 18 positioned or embedded within the main body 24 of thecatheter 22 allows a user such as a surgeon to monitor temperatureduring a medical procedure. As will be appreciated by those skilled inthe art, one or more FBGs may be used to monitor temperature duringtherapy delivery. Alternatively or additionally, one or more FBGs may beused to monitor medical device heating during scanning such that safelevels of heating may be maintained.

Generally speaking, an FBG is one type of distributed Bragg reflectorthat is constructed in a segment of optical fiber and is structured toreflect predetermined wavelengths of light and to transmit all otherstherethrough. This selective reflection is accomplished by adding aperiodic variation to the refractive index of the optical fiber core,thereby creating a wavelength specific dielectric mirror. Thus, FBGs actas “filters” to block or reflect certain wavelengths.

FBGs are typically formed in an optical fiber by either “writing” or“inscribing” the periodic (or aperiodic) variation of refractive indexinto the core of the optical fiber using an ultraviolet source. Themethods used to create the variations include “interference” and“masking.” The interference method, which may be useful for uniformgratings, utilizes an ultraviolet laser that is split into two separatebeams that interfere with one another to create a periodic intensitydistribution along the interference pattern. The magnitude of therefractive index is dependent upon the intensity of the laser lightused. The masking method, which is well-suited for the manufacture ofchirped FBGs, utilizes a photomask placed between an ultraviolet lightsource directed at the fiber and creates a grating structure based uponthe intensity of the light that impinges upon the fiber. In anothercommon method, an ultraviolet laser beam may be operated to “write” thegrating into the fiber point-by-point.

As appreciated by those skilled in the art, FBGs operate on a principleknown as “Fresnel reflection,” wherein light traveling between media ofdifferent refractive indices may be both reflected and refracted at theinterface. The grating of the FBG element includes a varying sinusoidalrefractive index over the length of the element. The wavelengthreflected by the grating, which is known as the Bragg wavelength, may beapproximated as follows:

Bragg wavelength=2ηΛ,

where η represents the average refractive index in the grating of thefiber and Λ represents the grating period.

The refractive index and the grating period are determined by thestructure of the FBG element. Generally speaking, there are six knownand common structures for FBGs, including chirped, superstructure,Gaussian apodized, discrete phase shift, uniform positive-only indexchange, and raised-cosine apodized.

Because the Bragg wavelength is sensitive to temperature, FBGs may beused as sensing elements in optical fiber sensors. In a FBG element, themeasurand causes a shift in the Bragg wavelength. The relative shift inthe Bragg wavelength due to an applied strain (ε) and a change intemperature (ΔT), may be approximated as follows:

Relative shift in Bragg wavelength=C _(S) ε+C _(T) ΔT,

wherein C_(S) is the coefficient of strain and C_(T) is the coefficientof temperature.

Based upon the foregoing relationship, FBGs may be used to directlysense the temperature and determine changes in temperature. Variousother methods of estimating temperature with FBGs are also possible. Amore detailed, exemplary method for estimating temperature using FBGswill be described in further detail to follow.

The fiber 14 of the temperature monitoring system 10 may be either asingle-mode or multi-mode fiber optic cable. As appreciated by thoseskilled in the art, single-mode fiber optical cables are structured forcarrying only a single ray or mode of light, which may contain a varietyof different wavelengths. Single-mode cables have a small light carryingcore, and are well-suited for long distance transmissions. Conversely,multi-mode fiber optic cables have a relatively larger light carryingcore, and are well-suited for short distance transmissions.

Although only one FBG element 18 is illustrated in FIG. 1, temperaturemonitoring systems having any number of FBG elements are within theintended scope of the present invention. In one exemplary embodimenteach FBG element may have an axial length (along the axis of the fiber)between about 2 mm and about 6 mm. However, the lengths of the FBGs maybe greater than 6 mm or less than 2 mm depending upon the requirementsand intended operation of the system. For example, in one alternativeembodiment the fiber may include a plurality of FBGs each having alength less than 2 mm in order to optimize spatial selectivity.

The optical transmit/receive circuitry 12 is illustrated as beingexternal to the catheter 14 of FIG. 1 merely for purposes of example andnot limitation. In alternative embodiments, the optical transmit/receivecircuitry 12 may instead be positioned within or embedded into themedical device in which the temperature is being monitored.

FIG. 3 is a block diagram illustrating the components of an exemplaryoptical transmit/receive circuitry 12. As illustrated in FIG. 3, theoptical transmit/receive circuitry 12 includes a light source 30, atunable filter 32, a scan generator 34, a processor 36, and a detector38. The light source 30 may be a narrowband or broadband light source(i.e. white light). The tunable filter 32 and the detector 38 areoperable to detect wavelength of the received light (i.e. tunablewavelength filter).

In operation, the scan generator 34 may tune the light source 30 bysweeping it across a predetermined range so that the wavelength of lightbeing transmitted down the fiber 14 is known at all times. When thewavelength emitted by the light source 30 matches the specified Braggwavelength of the FBG element 18, light is reflected back along thefiber 14 towards the detector 38. The scan generator 34 is operable totransmit a timing signal to the processor 36. This timing signal allowsthe processor to create a “spectrum” based upon the “intensity” versus“time” information it has received. The processor may be operable toidentify various characteristics of the spectrum such as peak positions,which may then be used to estimate temperature.

FIG. 4 is a block diagram illustrating the basic operation of thetemperature monitoring system 10 in accordance with the presentinvention. As shown in FIG. 4, light waves 40 (either narrowband orbroadband) are transmitted from the optical transmit/receive circuitry12 towards the FBG element 18. The FBG element 18 reflects apredetermined narrow or broad range of wavelengths of light 42 incidenton the grating while passing all other wavelengths of light 44. Thereflected wavelengths 42 are redirected back towards the opticaltransmit/receive circuitry 12 where they are detected by the tunablefilter 32 and the detector 38 as previously described above with regardto the system block diagram of FIG. 3.

FIG. 5 is a block diagram illustrating the basic operation of analternative temperature monitoring system 10A in accordance with thepresent invention. The temperature monitoring system 10A is similar tothe temperature monitoring system 10 previously described, but furtherincludes a second FBG element 45 positioned along the fiber 14. Becausewavelengths other than the Bragg wavelength are passed with little or noattenuation, multiple FBGs may be used on a single fiber. As shown inFIG. 5, light waves 40 (either narrowband or broadband) are transmittedfrom the optical transmit/receive circuitry 12 towards the FBG element18. The FBG element 18 reflects a predetermined narrow or broad range ofwavelengths of light 42 incident on the grating while passing all otherwavelengths of light 44. The reflected wavelengths 42 are redirectedback towards the optical transmit/receive circuitry 12 where they aredetected by the tunable filter 32 and the detector 38 as previouslydescribed above with regard to the system block diagram of FIG. 3. Thewavelengths of light 44 that are allowed to pass through the FBG element18 are directed towards the second FBG element 45, where a secondpredetermined narrow or broad range of wavelengths of light 46 arereflected back towards the optical/transmit receive circuitry 12 wherethey are also detected by the tunable filter 32 and the detector 38. Allother wavelengths of light 48 are passed through the second FBG element45 towards the distal end 20 of the fiber 14. As will be appreciated bythose skilled in the art, the FBG element 18 and the second FBG element45 must have their own wavelength segments to ensure that varioussignals do not overlap and the temperature monitoring system operatesproperly.

FIG. 6 is an exemplary embodiment of an implantable device 50 such as adefibrillator having the temperature monitoring system 10 of FIG. 1embedded therein. As illustrated in FIG. 6, the implantable device 50may be inserted under the skin of a patient P adjacent the heart 51, andmay generally include a main housing 52 along with one or more elongateelectrodes 53 insertable through a vein 54 and sized to extend into theright atrium 55 and the right ventricle 56. As will be appreciated bythose skilled in the art, the size and structure of the implantabledevice 50 may vary without departing from the intended scope of thepresent invention.

As further illustrated in FIG. 6, both the fiber 14 and the opticaltransmit/receive circuitry 12 are positioned or embedded within thehousing 52 such that the temperature monitoring system 10 is completelycontained within the implantable device 50. In operation, thetemperature monitoring system 10 is operable to sense temperatureadjacent to the implantation position of the housing 52. Although asingle FBG element that produces a corresponding single temperaturesensing location is shown, those skilled in the art will appreciate thatany number of FBG elements may be used to achieve any desired number oftemperature sensing locations within the housing 52 or along the axiallength of the electrodes 53 without departing from the intended scope ofthe present invention.

FIG. 7 is an exemplary embodiment of an ablation catheter 60 having thetemperature monitoring system 10A of FIG. 5 embedded therein. Asillustrated in FIG. 7, the ablation catheter 60 includes a generallytubular main body 62, an ablation tip 64, and a lumen 66 extending alongthe axial length of the main body 62 towards the ablation tip 64. Aswill be appreciated by those skilled in the art, the ablation catheter60 may be structured to deliver any suitable ablative therapy to theablation tip 64 through the lumen 66 including, but not limited to,radiofrequency energy, laser energy, microwave energy, highly focusedultrasound energy, cryogenic fluid and the like.

As further illustrated in FIG. 7, the embedded fiber 14 of thetemperature monitoring system 10A may be operable to sense temperatureat a first sensing location 68A adjacent to the FBG element 18 and at asecond sensing location 68B adjacent to the FBG element 45. Although theablation catheter 60 is shown as including two temperature sensinglocations 68A and 68B, any number of temperature sensing locations maybe created by simply varying the number of FBG elements in the fiber.Additionally, the axial positions of the temperature sensing locationsmay be altered by modifying the spacing between the FBG elements.

FIG. 8 is an exemplary embodiment of a biopsy needle device 70 havingthe temperature monitoring system 10 of FIG. 1 embedded therein. Asillustrated in FIG. 8, the biopsy needle device 70 includes a generallytubular main body 72, an open distal tip 74, and a lumen 76 extendingalong the axial length of the main body 72. As will be appreciated bythose skilled in the art, the size and structure of the biopsy needledevice 70 may vary without departing from the intended scope of thepresent invention.

As further illustrated in FIG. 8, the embedded fiber 14 of thetemperature monitoring system 10 may be operable to sense temperature ata single sensing location 78 adjacent to the FBG element 18. However, aswill be appreciated by those skilled in the art, any number of FBGelements may be used to achieve any desired number of temperaturesensing locations along the axial length of the biopsy needle device 70.Additionally, although the FBG element 18 of the fiber 14 is positionedsuch that it produces a temperature sensing location 78 adjacent to thedistal end of the main body 72, the temperature sensing location may bemodified by placing the FBG element at another axial location.

FIG. 9 is an exemplary embodiment of a stem cell delivery device 80having the temperature monitoring system 10 of FIG. 1 embedded therein.As illustrated in FIG. 8, the stem cell delivery device 80 includes acatheter 82 and a stem cell delivery needle 84. The catheter 82 includesa generally tubular main body 85 with an open distal end 86 structuredto allow the stem cell delivery needle 84 to pass therethrough. The stemcell delivery needle 84 includes an elongate main body 88 have a lumen90 therein. The fiber 14 with the FBG element 18 is embedded within thelumen 90 of the main body 88 of the stem cell delivery needle 84. Themain body 88 may include an aperture at a distal end that is structuredand sized for passing cell structures therethrough. As will beappreciated by those skilled in the art, the size and structure of thestem cell delivery device 80 may vary without departing from theintended scope of the present invention.

As further illustrated in FIG. 9, the embedded fiber 14 of thetemperature monitoring system 10 may be operable to sense temperature ata single sensing location 92 adjacent to the FBG element 18. As will beappreciated by those skilled in the art, a surgeon may move the stemcell delivery needle 84 relative to the open distal end 86 of thecatheter 84 in order to position the temperature sensing location at thedesired point (or as close as possible to the desired point) where thesurgeon wants to obtain a temperature reading. Similar to the medicaldevices previously described above, any number of FBG elements may beused to achieve any desired number of temperature sensing locationsalong the axial length of the stem cell delivery device 80.Additionally, although the FBG element 18 of the fiber 14 is positionedsuch that it produces a temperature sensing location 92 adjacent to thedistal end of the main body 88 of the stem cell delivery needle 84, thetemperature sensing location may be modified by placing the FBG elementat another axial location.

FIG. 10 is an exemplary embodiment of an interventional device deliverysystem 100 having the temperature monitoring system 10 of FIG. 1embedded therein. As illustrated in FIG. 10, the delivery system 100includes a generally tubular catheter body 102, an expansion means 104such as a balloon adjacent a distal end, and a lumen 106 extending alongthe axial length of the catheter body 102. In one exemplary embodiment,the lumen 106 may be structured for passage of an inflation means suchas air or saline for inflation and deflation of the expansion means 104.The delivery system 100 may be structured for delivery of any suitableinterventional device such as an expandable stent or the like.

As further illustrated in FIG. 10, the embedded fiber 14 of thetemperature monitoring system 10 may be operable to sense temperature ata single sensing location 108 adjacent to the FBG element 18. However,as will be appreciated by those skilled in the art, any number of FBGelements may be used to achieve any desired number of temperaturesensing locations along the axial length of the interventional devicedelivery system 100. Additionally, although the FBG element 18 of thefiber 14 is positioned such that it produces a temperature sensinglocation 108 adjacent to the distal end of the catheter body 102, thetemperature sensing location may be modified by placing the FBG elementat another axial location.

FIG. 11 is an exemplary embodiment of another alternative temperaturemonitoring system 10B in accordance with the present invention. Asillustrated in FIG. 11, the temperature monitoring system 10B is similarto the temperature monitoring system 10A, but further includes a thirdFBG element 110 and a fourth FBG element 112. As will be appreciated bythose skilled in the art based on the foregoing discussion, havingmultiple FBG elements positioned along an axial length of the fiber 14between the proximal end 16 and the distal end 20 allows for multiplepoint temperature measurements along a pathway in a medical device. Thistype of “pathway” temperature monitoring may be useful in any medicaldevice where it may be important to monitor temperature at more than onelocation, including but not limited to the devices previously described.As illustrated in FIG. 11, the spacing S between the various FBGelements may be equal or alternatively may vary by any desired amount.Thus, the temperature monitoring device 10B may be customized forparticular applications and uses.

Although the various embodiments of medical devices were described aboveas including a single fiber element, temperature monitoring systemsutilizing multiple fiber elements each having one or more FBG elementstherein are also possible. Thus, a single medical device such as anablation catheter may be structured with two or more fibers positionedor embedded therein. This type of design may be used for measuring thetemperature of one or more therapy delivery points or one or morelocations for safety monitoring during therapy delivery or delivery of amedical device using MRI guidance. Further, although the fiber and FBGelements of the temperature monitoring systems have been generallydescribed as embedded or removably positioned within the medicaldevices, they may alternatively be fixedly or removably coupled to anouter surface of the device without departing from the intended scope ofthe present invention.

As will be appreciated by those skilled in the art, the optical fibermay be positioned or embedded within a device, positioned on an outersurface of a device, or any combination thereof without departing fromthe intended scope of the present invention. For example, in oneexemplary embodiment the fiber may be partially exposed to the exteriorof the device. In another exemplary embodiment the device may include afiber with at least one portion completely positioned/embedded withinthe device and at least one additional portion positioned on theexterior of the device. Thus, numerous alternative designs arecontemplated and within the intended scope of the present invention.

As a Bragg diffraction grating system does not posses the technicalshortcomings of other temperature measuring techniques inside an MRIsystem, another alternative embodiment of the present invention mayinclude external in vitro or in vivo temperature measurement of amedical device. In this embodiment, a fiber optic cable having one ormore FBG elements is placed external to the medical device. As will beappreciated by those skilled in the art, this embodiment may be usefulin determining the safety of a medical device in MRI with regard tojoule heating at tissue/electrode interfaces, dielectric heating alongthe length of a metallic structure, gradient induced heating and thelike.

Although the temperature monitoring system of the present invention hasbeen described with reference to a discrete number of medical devices,those skilled in the art will appreciate that the temperature monitoringsystem may be incorporated into any medical device that is used in anMRI environment. Thus, the embodiments set forth herein have beendescribed merely for purposes of example and not limitation.

Now that several exemplary embodiments of the temperature monitoringsystem have been described with reference to various medical devices,one exemplary method of operating the temperature monitoring systems todetermine temperature measurements will be described in detail. Theexemplary method of the present invention may generally be separatedinto three processes, including determining bulk wavelength 200,calibrating temperature 300, and measuring temperature 400. Each ofthese processes will now be described with reference to FIGS. 12-19.

FIG. 12 is a flow diagram illustrating exemplary steps in the process ofdetermining bulk wavelength 200 in accordance with one embodiment of thepresent invention. Beginning with step 202, three wavelength values arepredefined. These wavelength values include the minimum wavelength,λmin, the maximum wavelength, λmax, and the wavelength step, λstep.Then, at step 204 the transmit wavelength, λtx, is set to the minimumwavelength, λmin.

Starting at the minimum wavelength, the optical transmit/receive unittransmits narrowband (or broadband) light into the proximal end of afiber containing one or more FBG elements at step 206. The lightreflected off of the one or more FBG elements is received and measuredby a photo detector in the optical transmit/receive unit at step 208,and the magnitude and transmit wavelength, λtx, are recorded into memoryat step 210.

A processor then determines whether the transmit wavelength, λtx, isgreater than or equal to the maximum wavelength, λmax, at step 212. Ifthe transmit wavelength, λtx, is determined to be less than the maximumwavelength, λmax, the transmit wavelength, λtx, is incremented by thewavelength step, λstep, at step 214 and the process 200 enters a loop216 where steps 206-212 are repeated for transmit wavelengths from λminto λmax at incremental steps of λstep. Once the processor determinesthat the transmit wavelength, λtx, is greater than or equal to themaximum wavelength, λmax, at step 212, this portion of the process iscomplete and a data set now exists consisting of transmit wavelengthsand associated received light magnitudes. An exemplary data set isrepresented by the graph in FIG. 13.

Although one exemplary method of forming the data set represented by thegraph in FIG. 13 has been described in detail, those skilled in the artwill appreciate that any suitable method may be used without departingfrom the intended scope of the present invention. One alternative methodis to transmit a broad spectrum of light down the fiber and measurereturn light intensity variations as the path difference in aninterferometer is varied. Another alternative method is to transmit abroad spectrum of light down the fiber and utilize a second fiber Bragggrating element with a known pass/reject ratio through which thereturned light is passed, wherein the intensities of the lighttransmitted through the second fiber Bragg grating element and the lightrejected by the second fiber Bragg grating element may be compared todetermine the wavelength of the returning light. Yet another alternativemethod is to transmit a broad spectrum of light down the fiber and splitthe returned light into several beams which may be fed into manynarrowband detectors, each narrowband detector being designed to detectlight at a specific wavelength. Yet another alternative method is totransmit multiple narrowband light signals down the fiber, each signalbeing centered at a different wavelength and each uniquely modulated orcoded such that the returned signal can be demodulated or decoded todetermine the corresponding intensity vs. wavelength characteristics. Aswill be appreciated by those skilled in the art, the foregoingalternative methods are presented merely for purposes of example and notlimitation.

For purposes of discussion and not limitation, the bulk wavelength maybe defined as a single wavelength value that represents the centerwavelength of the received light. To find the bulk wavelength, thewavelength at which the magnitude is maximum is first identified at step218. This step is depicted graphically in FIG. 14. Next, in step 220,the range of contiguous wavelengths (which includes the wavelength atwhich the magnitude is maximum) for which the corresponding magnitude isgreater than the maximum magnitude minus some threshold is determined.This range may be referred to as the “bulk range.” In one exemplaryembodiment the preferred threshold may be about 3 dB, although anysuitable threshold may be used as will be appreciated by those skilledin the art. The bulk wavelength is then calculated in step 222 as thecenter of mass of the magnitudes within the defined bulk range. Thisstep is also depicted graphically in FIG. 14. As illustrated in theexemplary graph of FIG. 14, the bulk range does not include the smallmagnitude peak to the left of the main peak. Once the bulk wavelength iscalculated at step 222, the process 200 may terminate at step 224.

As will be appreciated by those skilled in the art, bulk wavelength maybe calculated using numerous alternative methods without departing fromthe intended scope of the present invention. For example, bulkwavelength may be determined using peak detection (i.e. finding theabsolute peak magnitude value), filtered peak detection (i.e. filteringthe wavelength magnitudes followed by finding the absolute peakmagnitude value), filtered center of mass (i.e. filtering the wavelengthmagnitudes followed by finding the center of mass of the magnitudes), orthe like. Thus, the bulk wavelength process 200 is one of many processesthat may be used, and was discussed herein for purposes of example andnot limitation.

Turning next to FIG. 15, a flow diagram is presented illustratingexemplary steps in the process of calibrating temperature 300 inaccordance with one embodiment of the present invention. Beginning withstep 302, a plurality of known calibration temperature values areselected that will be used to perform the calibration procedure. Then,in step 304, a bulk wavelength, λbulk, is determined for each of theselected calibration temperature values. The result of the bulkwavelength determination step is depicted graphically in FIG. 16. Thesebulk wavelengths may be determined using the bulk wavelength process 200previously described, or any other known and suitable process fordetermining bulk wavelength. Once a bulk wavelength is determined foreach of the selected calibration temperature values in step 304, acalibration data set is formulated and stored in memory in step 306. Inone exemplary embodiment as depicted in the table set forth in FIG. 17,the calibration data set may be stored as a plurality of calibrationwavelengths, λcal, and a corresponding plurality of calibrationtemperatures, Tcal. Once the calibration data set is stored in memory,the calibration process may terminate at step 308. The storedcalibration data set may then be used in the temperature monitoringprocess 400 to determine the temperature at one or more temperaturesensing locations.

Turning next to FIG. 18, a flow diagram is presented illustratingexemplary steps in the process of measuring temperature 400 at one ormore temperature sensing locations in accordance with one embodiment ofthe present invention. Beginning with step 402, the current bulkwavelength, λbulk, is determined using any suitable bulk wavelengthdetermination process, such as the bulk wavelength process 200previously discussed. Next, the calibration data set is accessed frommemory in step 404. Using the calibration data set, an interpolation isperformed between the appropriate Tcal and λcal points at step 406 toestimate the current temperature based on the current bulk wavelength.This interpolation process is depicted graphically in FIG. 19. Theinterpolation step may use linear interpolation or any suitable higherorder interpolation, such as polynomial interpolation. If the currentbulk wavelength, λbulk, falls outside of the range of Tcal and λcalpoints in the calibration data set, step 406 may alternatively utilizeextrapolation to estimate the current temperature. This extrapolationprocess is depicted graphically in FIG. 20. As will be appreciated bythose skilled in the art, the extrapolation step may use linearextrapolation or any suitable higher order extrapolation, such aspolynomial extrapolation. Once the current temperature is determined instep 406, the temperature monitoring process may terminate at step 408.As will be appreciated by those skilled in the art, the temperaturemonitoring process 400 may be repeated at any desired time interval inorder to continuously or periodically monitor, with or without temporalinterpolation or extrapolation, temperature of a device.

Although several exemplary steps were described with reference to thebulk wave determination, temperature calibration, and temperaturemeasurement processes, those skilled in the art will appreciate that theorder and number of steps may be modified without departing from theintended scope of the present invention. Thus, the exemplary steps wereprovided merely for purposes of example and not limitation.

As will further be appreciated by those skilled in the art, theprocesses previously described may be embodied as a system, method orcomputer program product. Accordingly, the present invention may takethe form of an entirely hardware embodiment, an entirely softwareembodiment (including firmware, resident software, micro-code, etc.) oran embodiment combining software and hardware aspects that may allgenerally be referred to as a “circuit,” “module” or “system.”Furthermore, the present invention may take the form of a computerprogram product embodied in any tangible medium of expression havingcomputer usable program code embodied in the medium.

The processes comprising the method of the present invention have beendescribed with reference to flow diagrams illustrating exemplary steps.It will be understood that each block of the flowchart diagrams, andcombinations of blocks in the flowchart diagrams, can be implemented bycomputer program instructions. These computer program instructions maybe provided to a processor of a general purpose computer, specialpurpose computer, or other programmable data processing apparatus toproduce a machine, such that the instructions, which execute via theprocessor of the computer or other programmable data processingapparatus, create means for implementing the functions/acts specified inthe flowchart diagram block or blocks.

These computer program instructions may also be stored in acomputer-readable medium that can direct a computer or otherprogrammable data processing apparatus to function in a particularmanner, such that the instructions stored in the computer-readablemedium produce an article of manufacture including instruction meanswhich implement the function/act specified in the flowchart block orblocks.

The computer program instructions may also be loaded onto a computer orother programmable data processing apparatus to cause a series ofoperational steps to be performed on the computer or other programmableapparatus to produce a computer implemented process such that theinstructions which execute on the computer or other programmableapparatus provide processes for implementing the functions/actsspecified in the flowchart diagram block or blocks.

Although the present invention has been described with reference topreferred embodiments, workers skilled in the art will recognize thatchanges may be made in and detail without departing from the spirit andscope of the invention.

1. A temperature monitoring system for a medical device comprising: anoptical transmit/receive unit; an elongate optical fiber having aproximal end, a distal end, and an inner core extending between theproximal end and the distal end, the optical fiber operably coupled tothe transmit/receive unit at the proximal end; and a fiber Bragg gratingelement formed in the inner core of the optical fiber; wherein at leasta portion of the optical fiber is operably coupled to a medical deviceand is structured to measure temperature at a temperature sensinglocation on the medical device.
 2. The temperature monitoring system ofclaim 1, wherein the optical fiber is a single-mode fiber optic cable.3. The temperature monitoring system of claim 1, wherein the opticalfiber is a multi-mode fiber optic cable.
 4. The temperature monitoringsystem of claim 1, wherein the optical fiber is removably disposedwithin an interior portion of the medical device.
 5. The temperaturemonitoring system of claim 1, wherein the optical fiber comprises aproximal fiber segment that is coupled to the optical transmit/receiveunit and a separate distal fiber segment that is coupled to the medicaldevice.
 6. The temperature monitoring system of claim 5 furthercomprising a connector structured to operably couple the proximal fibersegment to the distal fiber segment.
 7. The temperature monitoringsystem of claim 1, wherein the fiber Bragg grating element has an axiallength between about 2 mm and about 6 mm.
 8. The temperature monitoringsystem of claim 1, wherein the optical transmit/receive unit is disposedwithin the medical device.
 9. The temperature monitoring system of claim1, wherein the optical transmit/receive unit includes a light sourceoperable to transmit light waves into the optical fiber and a scangenerator, wherein the scan generator is operable to tune the lightsource.
 10. The temperature monitoring system of claim 9, wherein thelight source is a narrowband light source.
 11. The temperaturemonitoring system of claim 9, wherein the light source is a broadbandlight source.
 12. The temperature monitoring system of claim 9, whereinthe optical transmit/receive unit further comprises a detector operableto detect wavelengths of light reflected from the fiber Bragg gratingelement.
 13. The temperature monitoring system of claim 12, wherein theoptical transmit/receive unit further comprises a processor operable toidentify one or more characteristics of the wavelengths of lightreflected from the fiber Bragg grating element.
 14. The temperaturemonitoring system of claim 1 further comprising a second fiber Bragggrating element formed in the inner core of the optical fiber formeasuring temperature at a second temperature sensing location on themedical device.
 15. The temperature monitoring system of claim 1,wherein the medical device is a catheter.
 16. The temperature monitoringsystem of claim 1, wherein the medical device is an implantable devicehaving the optical fiber and the optical transmit/receive unit embeddedtherein.
 17. The temperature monitoring system of claim 1, wherein aplurality of fiber Bragg grating elements are formed in the inner coreof the optical fiber for sensing temperature along a pathway, the fiberBragg grating elements axially spaced along the optical fiber by aseparation distance.
 18. The temperature monitoring system of claim 17,wherein the separation distance between adjacent fiber Bragg gratingelements is substantially constant.
 19. The temperature monitoringsystem of claim 17, wherein the separation distance between adjacentfiber Bragg grating elements varies along an axial length of the opticalfiber.
 20. A method of estimating temperature comprising: selecting aplurality of known calibration temperature values; determining a bulkwavelength for each of the calibration temperature values; formulating acalibration data set that includes the plurality of known temperaturevalues and the corresponding plurality of bulk wavelengths; and usingthe calibration data set to determine an estimated current temperaturevalue based upon a current bulk wavelength, wherein the currenttemperature value is estimated based upon one or more data points in thecalibration data set.
 21. The method of claim 20 further comprising thestep of providing a temperature monitoring system comprising: an opticaltransmit/receive unit; an elongate optical fiber operably coupled to thetransmit/receive unit at a proximal end; and a fiber Bragg gratingelement formed in an inner core of the optical fiber.
 22. The method ofclaim 21, wherein at least a portion of the optical fiber is operablycoupled to a medical device and is structured to measure temperature ata temperature sensing location on the medical device.
 23. The method ofclaim 21, wherein the bulk wavelengths are determined by transmitting alight wave into the proximal end of the optical fiber toward the fiberBragg grating element and measuring a reflected wavelength magnitude.24. The method of claim 20, wherein the step of determining a bulkwavelength for each of the calibration temperature values comprises:defining a minimum wavelength value and a maximum wavelength value; andtransmitting a plurality of light wavelengths between the minimumwavelength value and the maximum wavelength value to determine the bulkwavelength for each of the calibration temperature values.
 25. Themethod of claim 24 further comprising the step of defining a wavelengthstep value, wherein the light wavelengths are transmitted between theminimum wavelength value and the maximum wavelength value bysuccessively incrementing the transmitted wavelengths by an amount equalto the wavelength step value.
 26. The method of claim 24 furthercomprising the step of creating a data set that includes a plurality oftransmitted light wavelengths and a corresponding plurality of receivedlight magnitudes measured by a detector.
 27. The method of claim 26,wherein the bulk wavelength for each of the known calibrationtemperature values is determined by calculating a center of mass of thereceived light magnitudes within a bulk range.
 28. The method of claim27, wherein the bulk range is determined by identifying a maximumreceived light magnitude and determining a range of contiguouswavelengths for which the received light magnitudes are greater than themaximum received light magnitude minus a threshold value.
 29. The methodof claim 26, wherein the bulk wavelength for each of the knowncalibration temperature values is determined by finding a peak magnitudevalue of the received light magnitudes.
 30. The method of claim 20,wherein the current temperature value is estimated by interpolatingbetween two or more data points in the calibration data set.
 31. Themethod of claim 30, wherein the current temperature value is estimatedusing linear interpolation.
 32. The method of claim 30, wherein thecurrent temperature value is estimated using polynomial interpolation.33. The method of claim 20, wherein the current temperature value isestimated using extrapolation.
 34. The method of claim 33, wherein thecurrent temperature value is estimated using linear extrapolation. 35.The method of claim 33, wherein the current temperature value isestimated using polynomial extrapolation.
 36. The method of claim 20,wherein the step of using the calibration data set to determine anestimated current temperature value based upon a current bulk wavelengthis repeated at a predefined time interval to periodically monitortemperature of a device.
 37. A temperature monitoring system for amedical device comprising: an optical transmit/receive unit; an elongateoptical fiber having a proximal end, a distal end, and an inner coreextending between the proximal end and the distal end, the optical fiberoperably coupled to the transmit/receive unit at the proximal end; andone or more fiber Bragg grating elements formed in the inner core of theoptical fiber; wherein at least a portion of the optical fiber ispositioned on an external surface of a medical device such thattemperature may be sensed at one or more temperature sensing locationson the medical device.